Combination inhalation therapeutic and exhalation measuring device

ABSTRACT

A combination spirometer or peak flow meter and nebulizer system is provided. Utilization of common elements, on a time sharing basis is accomplished by the combined instrumentation. The sharing of a common chamber by a peak flow meter and a nebulizer system is controlled by valves operated in response to phases of the respiratory process of a patient. With this combination vaporized medication is provided to a patient for inhalation during the inhale phase of the respiration cycle and the effectiveness of the inhaled medication is monitored by measuring the rate of flow of the breath exhaled during the exhale phase of the same respiratory cycle.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to the field of respiratory therapy. Inparticular, the invention is a unique medical instrumentation combininga meter for measuring the peak ability for exhalation of a patient withthe administration of inhalation therapy for the patient.

2. Prior Art

Peak flow meters for measuring the maximum rate at which air is forcedfrom the lungs during exhalation are used by inhalation and respiratorytherapists and physicians for monitoring a patient's respiratorycondition for diagnosing potential and/or existing breathing problems.The meter generally comprises an open ended cylinder, marked with agraduated scale along its length. The patient breaths into the openended cylinder, through a mouth piece, the patient's breath impingingagainst a biased diaphragm. The biased diaphragm is moved down thecylinder, along the scale thus indicating a rate at which breath isexhaled from the lungs. A nebulizer is a device often used by inhalationand respiratory therapists and physicians for administering vaporizedmedication to a patient, presenting vaporized medication to a patientthrough an aerosol chamber or vapor holding cylinder. Through a mouthpiece, at an end of the vapor holding cylinder, a patient inhalesvaporized medication. Peak flow meters and nebulizers are each wellknown and often used medical instrumentations. The U.S. Pat. No.4,944,306, issued to Alvino, Jul. 31, 1990 teaches an improved, patientadjustable, viewable, exhalation flow rate metering device orspirometer, also called a peak flow meter. A vertical housing, open atits upper end, connects, at its lower end to an horizontal cylinder witha mouth piece at one end and an open end at the other end. Theconnection between the vertical housing and the cylinder is at a pointbetween the mouth piece and the open end of the cylinder. The verticalhousing supports a biased piston on a positioning rod. The biased pistonis in full view of the patient exhaling into the mouth piece andcylinder. Exhaled breath from the patient forces the biased piston upthe positioning rod. The patient watches the piston rise up thepositioning rod as the patient blows into the mouth piece. U.S. Pat. No.5,565,630, issued to Shene, Oct. 15, 1996 teaches an improved peak flowmeter for measuring peak exhalation air flow of a patient. Breath isexhaled, from the mouth, through a mouth piece, into a hollow chambercontaining a biased, movable member which moves along the hollow chamberin response to pressure. A series of vent holes are provided in the wallof the chamber, along the path of the biased member. The holes increasein diameter as the length of the path increases. A graduated scale ismarked on the cylinder, along the path. The biased, movable member movesalong the path and graduated scale in response to pressure of a person'sor patient's breath exhaled into the mouth piece. The position of thebiased, movable member, along the graduated scale, indicates a peakbreath flow of a person's exhalation.

Nebulizers which meter vaporized medication to a person, are well knownin the medical field. Examples of United States issued patents are:

#3,353,536 issued to F.M. Bird et al Nov. 21, 1967 #4,470,412 issued toNowacki et al Sept. 11, 1984 #5,040,527 issued to Larson et al Aug. 20,1991 #5,363,842 issued to Mishelevich et al Nov. 15, 1994 #5,415,161issued to Ryder May 16, 1995 #5,431,154 issued to Seigel et al Jul. 11,1995 #5,743,252 issued to Rubsamen et al Apr. 28, 1998

The U.S. patent to F. M. Bird et al, U.S. Pat. No. 3,353,536 teaches anebulizer which is essentially a fixed or stable unit and can be usedfor long term use. A relatively large container supports a large amountof liquid medication. Air, flowed into a large quantity of liquidmedication, vaporizing the liquid which, in vapor form is presented tothe patient for inhalation. The unit is designed for long term therapywhere oxygen or air is administered to a patient. The U.S. Pat. No.4,470,412, issued to Nowacki et al, teaches an inhalation valve for anantiasthmatic medication cartridge assembly. A pressurized cannister orcartridge containing a suitable medication for inhalation is used fordispensing high velocity bursts of a pressurized medicated inhalant, invaporized form, into a sealed chamber. One end of the chamber is sealedby a slit diaphragm valve with an open mouth piece on the output side ofthe split valve. The valve opens when the patient inhales, passing thevaporized medication to the patient for inhalation. The dosage ofvaporized medication is user controlled. The slit valve fails to retainbursts of vaporized medication from the cannister containing pressurizedmedication.

The U.S. Pat. No. 5,040,527, issued to Larson et al; U.S. Pat. No.5,363,842, issued to Mishelevich et al; U.S. Pat. No. 5,415,161, issuedto Ryder; and U.S. Pat. No. 5,743,252, issued to Rubsamen et al eachteach the use of a replaceable cannister containing a pressurizedaerosol inhalant, a vaporized medication, under high pressure. Uponrelease from the cannister, an high velocity burst of vaporizedmedication is entrapped in and fills a patient breathing cylinder andmouth piece through which the patient is breathing. The high velocityburst of medication from the pressurized cannister results in an excessportion of the drug being administered to the patient and depositing theexcess portion in the patient's mouth. The high velocity burst ofmedication from the pressurized cannister also results in a loss ofmedication through the openings in the breathing cylinder. U.S. Pat. No.5,431,154, issued to Seigel et al also teaches the use of a replaceable,aerosol cannister of vaporized medication under pressure and furtherteaches limiting the pressure of the burst of high velocity spray ofmedication after the burst is released from the cannister.

The U.S. Pat. No. 5,522,380, issued to Dwork and U.S. Pat. No.5,839,430, issued to Cama each teach a combination peak flow meter andmetered dose inhaler. However, each patent teaches the use of apressurized cannister which contains vaporized medication under highpressure. In the case of Cama, the complete cannister of pressurizedmedication is inserted into the breathing chamber of the device so thatbursts of medication are emitted from the cannister directly into themouth piece of the device and therefore into the mouth of the patient.In the case of Dwork, in the output nozzle of the high pressurecannister is inserted directly into the breathing chamber of the device.In each case, the high velocity burst of medication into the breathingchamber deposits an huge amount of medication into the mouth of thepatient and medication is lost out the vent hole in the breathingchamber. Dosage from the cannister, in bursts of high velocitymedication, is patient controlled. By depositing high velocity bursts ofmedication directly into the chamber or cylinder of the peak flow meter,medication is lost up the calibrated cylinder of the peak flow meter andinaccuracy in the peak flow meter is amplified by getting the movablediaphragm, in the case of Cama, and a ball float in the case of Dwork,wet from the vaporized medications burst into the unit.

SUMMARY OF THE INVENTION

The present invention provides a peak flow meter and nebulizer, combinedto provide patients and clinicians with an improved medical device whichdelivers vaporized medication to a patient, for inhalation, and monitorsthe patient's air intake during the same respiratory cycle. Peak flowrate meters may be used to determine the severity of air flowobstruction caused by the swelling of tissue in the respiratory system.Monitoring the peak flow rate directly after medication for relief ofair flow obstruction has been taken, can determine the immediateeffectiveness of the medication.

A peak flow meter consists of an open ended chamber for capturingexhaled breath, in an expandable space, for measuring the flow rate ofbreath expelled from a patient. The exhaled breath-capturing chamber orbreathalizer chamber is an open ended chamber, with a mouth piece at theother end. The chamber houses a lightly biased, movable baffle ordiaphragm which moves within the chamber in accordance with the flowrate of breath exhaled into the chamber. A graduated scale, marked alongthe cylinder is used for measuring the breath exhaled into the cylinder.The nebulizer is a medication delivery device or system which deliversmedication, in vaporized or mist form, for inhalation by a patient. Thenebulizer includes a vapor or mist capturing chamber or breathalizerchamber, which is open at one end, with a mouth piece at the other end.The vaporized medication capturing chamber or breathalizer chamberpermits the patient to inhale, unobstructedly, the vaporized medicationdelivered to the breathalizer chamber, along with air.

From one aspect of the invention, there is provided a peak flow meterand a nebulizer, connected so as to use a common breathalizer chamber.The peak flow meter comprises an opened cylinder with a mouth piece atthe other end. A lightly biased baffle or diaphragm is supported in thebreathalizer chamber for capturing exhaled breath and defining a spacein the breathalizer chamber, which is a function of the flow rate of thebreath exhaled from a patient through the mouth piece. The nebulizer isa vapor or mist generating and delivery device or system which convertsa liquid medication, for example, into a mist or vaporized medication bybubbling air or oxygen, under low pressure, through the liquidmedication. The vaporized medication is delivered to a patient forinhalation, along with air or oxygen. In accordance with the presentinvention, vaporized medication of a nebulizer is delivered to thecommon breathalizer chamber, for inhalation, with air or oxygen. A oneway valve is provided between the common breathalizer chamber and thevaporization unit of the nebulizer. Connection by the medicationvaporization unit of the nebulizer to the breathalizer chamber is at apoint between the normal position of the lightly biased diaphragm andthe mouth piece at the end of the breathalizer chamber. A one way valvebetween the vaporization unit and the common chamber maintains theintegrity of the measurement of the peak flow meter and permits deliveryof the vaporized medication. The one way valve may be an automatic leafvalve or ball check valve or may be a manually operated, spring loadedsliding plate valve or a rotatable ball channel valve.

From another aspect of the invention, a peak flow meter and a nebulizerare combined with individual corresponding units in parallelrelationship where the corresponding units have common ends and a valvefor connecting a common mouth piece to the respective correspondingunits. A single cylinder or elongated chamber, with a mouth piece at oneend and an open end at the other end, is divided into two, essentiallyparallel chambers by a common wall. One chamber serves as a breathalizerchamber for the peak flow meter and the other chamber serves as abreathalizer chamber for the nebulizer system. The common mouth piece atone end of the single cylinder includes a valve that shuts off onebreathalizer chamber from the common mouth piece and opens the otherbreathalizer chamber to the common mouth piece. The valve may be amanually operable valve, such as a rotatable half open disk valve or anautomatic valve such as a double leaf one way valve, with one leaf ofthe double leaf valve opening in response to exhalation through themouth piece and closing in response to inhalation through the mouthpiece while the second leaf of the double leaf valve closes in responseto exhalation through the mouth piece and opens in response toinhalation through the mouth piece.

From a further aspect the invention provides a spirometer or peak flowmeter combined with a nebulizer which share common components. Eachdevice utilizes common components individually, to the exclusion of theother, on a time share basis. The time shared is the time of therespiratory cycle of a patient.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a representation of a preferred embodiment of the invention,in pictorial view;

FIG. 1a is a representation of a view along line a—a in FIG. 1;

FIG. 1b is a representation of a view along line b—b in FIG. 1;

FIG. 2 is a representation of an alternate embodiment of the invention,in pictorial view;

FIG. 2a is a representation of a view along lines a—a in FIG. 2 showinga rotatable disk valve;

FIG. 2a′ is a representation of a view along lines a—a in FIG. 2 showinga dual leaf valve, with the leafs operable in opposite directions,respectively;

FIG. 2b is a representation of a view along lines b—b in FIG. 2:

FIG. 3 is a representation of a rotatable mouth piece half-block valveusable in the invention;

FIGS. 4a and 4 b are representations of a ball channel valve indifferent positions, the ball channel valve usable in the invention;

FIG. 4c is a representation of a four leaf split one way valve usable inthe invention; and

FIG. 4d is a representation of a ball check valve, usable in theinvention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 represents a preferred embodiment of the invention where a commonchamber for the collection and measurement of the rate of flow ofexhaled breath and for the deposition of a vaporized medication forinhalation is provided. A cylinder or chamber 10 is open ended at 11 andhas a mouth piece 12, at the other end. Within the cylinder is a guidewire member 14 for a displaceable diaphragm or baffle 16. The diaphragm16 is lightly biased by a hair spring 18, so as to return to its normalposition, in absence of breath exhaled into the mouth piece.

The cylinder or breathalizer chamber 10 is preferably fabricated from aclear material, such as plastic, for example so that one may easily viewthe diaphragm 16, on the inside of the cylinder. A graduated scale ismarked on the wall of the cylinder so that the location of the diaphragmcan be noted. The diaphragm is positioned a few marks beyond thebeginning of the scale to account for the bias, which is very light butsufficient to return the diaphragm to its normal position.

The vaporization unit of the nebulizer system is connected to thebreathalizer chamber 10 at a point between the mouth piece 12 and the atrest position of the diaphragm 16. A one way valve 20 closes off thevaporization unit of the nebulizer from the breathalizer chamber 10,during periods of exhalation by the patient. The valve 20 is representedin its open condition in FIGS. 1a and 1 b. The valve 20 is representedas a spring loaded, push disk valve, for convenience, although an oneway split leaf, automatic valve is preferred. The valve 20 includes anopen center housing 22 which supports a spring or bias means, not shown,and a disk or plate 24. The biased push valve is represented mostlyclosed, in broken line form in FIG. 1b. The vaporization unit of thenebulizer includes a container 25 with that is thread-connected to thecap 26. The output of cap 26 is connected to the input side of the valve20. A ported distribution cap 28, with a top port 29 sits off the bottomof the container 25 so that when gas 31, such as air or oxygen, forexample, from the pump 30, is blown into the ported cap 28 of thecontainer 25, the gas will be distributed out the top port 29 of theported cap 28 and out, under the flanged base 27. When a liquid is inthe container 25, the gas 31 pumped into the container by the pump 30,is driven into the ported distribution cap 28, out of the top and bottomof the cap and into the liquid, mixing with the liquid, forming a mistor vapor of the liquid and gas. This instrumentation is used forvaporizing liquid medication placed in the container 25, andadministrating the vaporize liquid medication to a patient, byinhalation. A baffle 32 blocks direct access of the vaporized mass tothe valve 20 and hence to the breathalizer chamber 10. With the valve 20open, the vaporized mass is flowed gently into the breathalizer chamberfor inhalation by a patient through the mouth piece 12. FIG. 4crepresents an automatic valve 35 that may be substituted for the valve20, represented in FIG. 1b, in an alternative embodiment. The valve 35is a four leaf, one way valve. Each of the four leafs 36, 37, 38 and 39are connected to the rim of the housing 40 and each of the leafs lay onthe same side of the radial bars 42, 42′ 43 and 43′. FIGS. 4a and 4 brepresent another alternate valve, a channeled ball valve, that may besubstituted for the biased disk valve at 20. FIG. 4a represents a valveposition, with the main channel 45 open and the minor or vent channel 47closed. FIG. 4b represents a valve position, with the main channel 45closed and the vent channel 47 open. The channeled ball valve is amanual operated valve and is manually rotated to change position of thechannels. FIG. 4d represents another automatic valve that may be used atthe position of valve 20. FIG. 4d represents a ball check valve. Theball 48 sits in the valve seat, the weight of the ball holding againstthe low pressure of the vaporized mass 50 in the container 25. Uponinhalation through the mouth piece 12, the ball is unseated, opening thevalve, permitting the vaporized medication to pass through the valve andenter the breathalizer chamber. Upon exhalation, the ball is seated inthe valve seat, closing the valve, maintaining the integrity of the peakflow measurement.

FIG. 2 represents an alternate embodiment of the invention. The peakflow meter and nebulizer system share a common mouth piece and haveseparate breathalizer chambers, each of which have a common wall andcommon ends open. The alternate embodiment of the invention comprises acylinder 55 separated into two chambers, 57 and 58 by a divider wall 60.The breathalizer chamber 57 supports a guide means 62 on which a baffleor diaphragm 64 rides. The diaphragm 64 is biased by an hair spring 65,which returns the diaphragm 64 to its at rest position in thebreathalizer chamber 57. A mouth piece 66 is connected to the cylinder55 at one end, with a valve 67 at the internal end of the mouth piece.The valve 67 may be similar to the valve 67 a represented in FIG. 2a.The valve represented is a manually rotatable, disk valve, half of whichis open 63 and half of which is closed 61. The valve may be rotated foropening one chamber, for example 58, to the mouth piece 66 and closingthe other chamber 57, to the mouth piece 66, then rotated to a reversecondition.

Alternatively, the valve represented in FIG. 2a′ may be used. The valverepresented in FIG. 2a′ is an automatic two way double leaf valve. Oneleaf 68 is secured to an arcuate section 69 on the ring housing 71 andopens, for example, outwardly, as indicated by arrow 70. The other leaf72 is secured at an arcuate section 74 on the ring housing 71 and opens,for example, inwardly, as indicated by the arrow 75. The free ends ofeach leaf rest on opposite sides, respectively of the diameter bar 77.When operating, one leaf is open and the other leaf is closed.

As an alternative to the valve at 67, the mouth piece 66 may be used asa valve. As shown in FIG. 3 the mouth piece 80 includes an open section82 and a closed section 84. The open section 82 may be aligned with thechamber 57, thus closing chamber 58 by the closed or blocking section84. The mouth piece may be rotated to reverse the condition. Thenebulizer system of the embodiment in FIG. 2 includes the breathalizerchamber 58 and vaporizer 85. The vaporizer 85 may be similar to thevaporizer represented in FIG. 1, with a pump pumping air or oxygenthrough the tubing 87. With an automatic two way valve at 67, forexample, the alternate embodiment of the invention may be used toadminister inhalation medication during the inhale stage of therespiration process and the peak flow of the patient may be measuredduring the exhale stage of the respiration process.

In the foregoing description of the invention, referenced to thedrawings, certain terms have been used for conciseness, clarity andcomprehension. However, no unnecessary limitations are to be impliedfrom or because of the terms used, beyond the requirements of the priorart, because such terms are used for descriptive purposes and areintended to be broadly construed. Furthermore, the description andillustration of the invention are by way of example, and the scope ofthe invention is not limited to the exact details shown, represented ordescribed.

Having now described a preferred embodiment of the invention, in termsof features, discoveries and principles, along with certain alternativeconstruction and suggested changes, other changes that may becomeapparent to those skilled in the art may be made, without departing fromthe scope of the invention defined in the appended claims.

What is claimed is:
 1. A clinical respiration therapy device comprising:a) a chamber means defined by a cylindrical body having an open end atone end and a mouth piece means at the other end, said cylindrical bodyhaving a graduated scale marked along said cylindrical body, saidgraduated scale marking a volume of space of said chamber from a minorvolume space to a major volume space, said minor volume space defined byan indicator means spaced from said mouth piece means; b) a guide meansextending along said chamber means from said mouth piece means to saidopen end and supporting said indicator means, said indicator means forbeing displaced along said guide means from a position indicating saidminor volume space in response to the flow rate of breath exhaled intosaid chamber means through said mouth piece means; c) an input portmeans in said cylindrical body opening into said minor volume space; d)a one way valve means across said input port means for preventing breathexhaled into said chamber means from escaping said chamber means throughsaid input port means; e) a container means having an input means and anoutput means, said container means adapted for holding a liquid withinsaid container means, said input means for receiving a gas underpressure for mixing with said liquid in said container means forgenerating a vaporized mass; and f) said output means coupled to saidone way valve means for depositing said vaporized mass into said chamberin said minor volume space.
 2. A clinical respiration therapy device asin claim 1, and further including a pump means for pumping said gas intosaid container means at a low pressure.
 3. A clinical respirationtherapy device as in claim 2, wherein said gas is air and said liquid isa medication preparation.
 4. A clinical respiration therapy device as inclaim 2, wherein said gas is oxygen and said liquid is a medicationpreparation.
 5. A clinical respiration therapy device as in claim 1wherein said one way valve means is a leaf valve biased to hold saidvaporized mass in said container means and said leaf valve opens uponinhalation through said mouth piece means.
 6. A clinical respirationtherapy device as in claim 1 wherein said one way valve means is abiased disk push valve.
 7. A clinical respiration therapy devicecomprising: a) a cylindrical body having an open end at one end and amouth piece means at another end and a common wall means for separatingsaid cylindrical body into a first chamber and a second chamber, saidcommon wall means extending from said open end to said mouth piecemeans; b) a guide means extending along said first chamber andsupporting an indicator means, said indicator means for being displacedalong said guide means from a position indicating a minor volume spacein said first chamber to another position, toward a major volume spacein said first chamber, in response to breath exhaled into said firstchamber through said mouth piece means; c) a port means in saidcylindrical body providing a first input means into said second chamber;d) a valve means between said mouth piece means and said cylindricalbody, said valve means having a first condition and a second condition,said first condition for closing access for said mouth piece means tosaid second chamber and opening access for said mouth piece means tosaid first chamber, said second condition for opening access for saidmouth piece means to said second chamber and closing access for saidmouth piece means to said first chamber; e) a container means having asecond input means and an output means, said container adapted forholding a liquid, said second input means for receiving a gas underpressure and for mixing said gas with said liquid for generating avaporized mass; and f) said output means coupled to said first inputmeans for delivering said vaporized mass into said second chamber.
 8. Aclinical respiration therapy device as in claim 2 wherein said firstchamber includes a graduated scale marked along an uncommon wall of saidfirst chamber defining volume of space in said first chamber.
 9. Aclinical respiration therapy device as in claim 3 wherein said indicatormeans is driven along said guide means by a breath exhaled through saidmouth piece means and said indicator means indicates a space in saidfirst chamber corresponding to a rate of flow of said breath.
 10. Aclinical respiration therapy device as in claim 2, wherein said valvemeans is an automatic, bidirectional, split leaf valve.
 11. A clinicalrespiration therapy device as in claim 2, wherein said valve means is arotatable disk valve, with half of said rotatable disk open.